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Archive for the ‘Clinical Trials’ Category

NIH Launches New Clinical Research Trials Web Site for the Public and Health Care Providers!

The National Institutes of Health has created a new web site, NIH Clinical Research Trials and You, to help people learn more about clinical trials, why they matter, and how to participate. Clinical trials are essential for identifying and understanding ways to prevent, diagnose, and treat disease. Research has shown that among the greatest challenges to recruitment of volunteers is the lack of general knowledge about what trials involve, where they are carried out, and who may participate.

Visitors to the web site will find information about:
•The basics of clinical trial participation
•First-hand experiences from actual clinical trial volunteers
•Explanations from researchers
•Links on how to search for a trial or enroll in a research matching program

In addition, health care professionals can read about evidence-based strategies for talking with patients about trials, print audience-tested posters to help promote trials in clinics and offices, and find other educational materials. NIH supports clinical research trials across the country and throughout the world. NIH’s ongoing effort to raise awareness about clinical research and educate potential participants about clinical trial options is vital to developing public support and understanding for how clinical research drives medical discovery and improves health outcomes.

PubMed Health Adds DARE and NCI PDQ

With its December update, PubMed Health grows to over 18,000 systematic reviews and health technology assessments in the last ten years. With the inclusion of the Database of Reviews of Effects (DARE) from the Centre for Reviews and Dissemination in England, PubMed Health is getting close to comprehensive coverage of reliable systematic reviews on clinical effectiveness.

Other new features and content additions in this release include:

  • Evidence-based, regularly updated information on cancer for consumers and health professionals from the National Cancer Institute (NCI) Physician Data Query (PDQ) database.
  • Two full-text books under “Understanding research results” from the “Understand clinical effectiveness” tab:
    Irwig L, et al. Smart Health Choices: Making Sense of Health Advice. London: Hammersmith Press; 2008. Available from: http://www.ncbi.nlm.nih.gov/books/NBK63638/
    Evans I, et al. Testing Treatments: Better Research for Better Healthcare. 2nd edition. London: Pinter & Martin; 2011. Available from: http://www.ncbi.nlm.nih.gov/books/NBK66204/
  • Simplified and broadened display of medical encyclopedia search results.

For more information and screenshots of the December 2011 additions to PubMed Health, please visit NLM Technical Bulletin and PubMed Health.

Clinical Alert: Commonly Used Three-drug Regimen for Idiopathic Pulmonary Fibrosis Found Harmful NIH Stops One Treatment Arm of Trial; Other Two Treatments to Continue

The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, has stopped one arm of a three arm multi-center, clinical trial studying treatments for the lung-scarring disease idiopathic pulmonary fibrosis (IPF) for safety concerns. The trial found that people with IPF receiving a currently used triple-drug therapy consisting of prednisone, azathioprine, and N-acetylcysteine (NAC) had worse outcomes than those who received placebos or inactive substances.

The interim results from this study showed that compared to placebo, those assigned to triple therapy had greater mortality (11 percent versus 1 percent), more hospitalizations (29 percent versus 8 percent), and more serious adverse events (31 percent versus 9 percent) and also had no difference in lung function test changes. Participants randomly assigned to the triple- therapy arm also remained on their assigned treatment at a much lower rate (78 percent adherence versus 98 percent adherence).

The other two study arms, or intervention groups, of this IPF trial comparing NAC alone to placebo alone will continue. In stopping this part of the trial, the NHLBI accepted the recommendation of the Data and Safety Monitoring Board (DSMB) – an independent advisory group of experts in lung disease, biostatistics, medical ethics, and clinical trial design. The DSMB has been monitoring the study since it began.

Please visit the NLM website to read the entire clinical alert.

PubMed Health — A Growing Resource for Clinical Effectiveness Information

PubMed Health is a service provided by the National Center for Biotechnology Information (NCBI) at the U.S. National Library of Medicine (NLM). PubMed Health specializes in reviews of clinical effectiveness research, with easy-to-read summaries for consumers as well as full technical reports. Clinical effectiveness research finds answers to the question “What works?” in medical and health care. With the August and September 2011 releases, the PubMed Health homepage was redesigned and the number of items based on systematic reviews increased significantly.

PubMed Health is based on systematic reviews of clinical trials. These clinical effectiveness reviews can show what treatments and prevention methods have been proven to work, and what remains unknown. PubMed Health provides summaries and full texts of selected systematic reviews in one searchable resource. The reviews are generally published or updated from 2003. There is also information for consumers and clinicians based on those reviews. A search on PubMed Health runs simultaneously in PubMed’s “Clinical Queries” Systematic Reviews, using a filter to identify all the indexed scientific articles at the NLM that might be systematic reviews. This search includes articles prior to 2003.

Information partners selected by PubMed Health to contribute their clinical effectiveness information are:

  • Agency for Health Care Research and Quality (US) (AHRQ)
  • The Cochrane Collaboration (CC)
  • German Institute for Quality and Efficiency in Health Care (IQWiG)
  • National Health Service (NHS) National Institute for Health Research (NIHR) Health Technology Assessment Programme (NIHR HTA)
  • National Institute for Health and Clinical Excellence guidelines program (NICE)
  • Oregon Health and Science University’s Drug Effectiveness Review Project (DERP)
  • Department of Veterans Affairs’ Evidence-based Synthesis Program from the Veterans Health Administration R&D (VA ESP)

Other key sections of PubMed Health include England’s Behind the Headlines service from the National Health Service (NHS Choices), medical encyclopedia from A.D.A.M. Education, and medication information from the American Society of Health-Systems Pharmacists.

To learn more about PubMed Health, including details about content and organization of the web site, please read the NLM Technical Bulletin or visit PubMed Health at http://www.pubmed.gov/health/.

Clinical Advisory: NINDS Stops Treatment with Combination Antiplatelet Therapy Due to Higher Risk of Major Hemorrhage and Death

NINDS has stopped the combination antiplatelet intervention in the Secondary Prevention of Small Subcortical Strokes (SPS3) trial. This was a randomized, multicenter clinical trial conducted throughout North America, Latin America and Spain, to learn about preventing a second stroke in patients who had a subcortical stroke and to learn how to prevent cognitive problems after a stroke. Visit the NLM website for further information about the trial.

Clinical Alert: Angioplasty Combined with Stenting Plus Aggressive Medical Therapy vs. Aggressive Medical Therapy Alone for Intracranial Arterial Stenosis

The National Institute of Neurological Disorders and Stroke (NINDS) has stopped enrollment in a clinical trial that is evaluating whether intracranial angioplasty combined with stenting adds benefit to aggressive medical therapy alone for preventing stroke in patients with symptomatic intracranial arterial stenosis. The study was the first prospective randomized multicenter trial to compare aggressive medical management alone versus aggressive medical management plus angioplasty combined with stenting in patients with symptomatic highgrade stenosis of a major intracranial artery. Recruitment began in November of 2008 and was halted on April 5, 2011 after 451 (59%) of the planned 764 patients had been enrolled at 50 participating sites in the US.

At the time of the most recent DSMB review, 14% of patients treated with angioplasty combined with stenting experienced a stroke or died within the first 30 days after enrollment compared with 5.8% of patients treated with medical therapy alone, a highly significant difference. The SAMMPRIS Executive Committee is in agreement with NINDS and the DSMB that enrollment in the study should be stopped and that the trial data currently available indicate that aggressive medical management alone is superior to angioplasty combined with stenting in patients with recent symptoms and high grade intracranial arterial stenosis. All are indebted to the patients who contributed to this important study.

Read the entire clinical alert at http://www.nlm.nih.gov/databases/alerts/intracranial_arterial_stenosis.html

What NIH Grantees Need to Know About ClinicalTrials.gov and FDAAA

NIH’s Office of Extramural Research has a new web site that provides information to help NIH applicants and grantees (recipients of extramural grants and cooperative agreements)  understand their roles and responsibilities in relation to ClinicalTrials.gov and the Food and Drug Administration Amendments Act (FDAAA) of 2007.  The information on this site may not apply to NIH contracts or NIH intramural research.

This site includes:

  • an overview of FDAAA and its relationship to certain trials funded through NIH grants and cooperative agreements;
  • an overview of registration and results reporting requirements;
  • instructions for providing the NIH with certification of compliance with FDAAA; and
  • FAQs for NIH grantees, definitions and acronyms, and other resources.

The site is available at: http://grants.nih.gov/ClinicalTrials_fdaaa/index.htm.